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This example assumes a simple parallel design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

• Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
• Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
• Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.

There are no other experimental factors of interest specified in the study design. This example corresponds to Trial Elements Example 1 (see Section 7.2.1.2, Examples for Trial Elements (TE) Domain Model) and the Trial Arms example (see Section 7.3.1.2, Example for Trial Arms (TA) Domain Model). There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the sponsor has chosen to provide a small amount of additional information about each trial set, including the associated arm code, sponsor-defined protocol group number, control group type, group label, and dose level and units, and the sponsor has made the assumption that male and female animals will be compared separately when relevant.